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New shot aims to ease depression and anxiety in cancer and chronic disease patients

NCT ID NCT07002034

Symptom relief Sponsor: Reunion Neuroscience Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study tests whether a single injection of RE104 can reduce symptoms of depression or mixed depression and anxiety in people with adjustment disorder caused by a serious medical illness like cancer, ALS, multiple sclerosis, Parkinson's disease, or idiopathic pulmonary fibrosis. About 100 participants will receive either a higher or lower dose of RE104 to compare safety and effectiveness. The goal is to see if this treatment can help patients feel better emotionally without long-term medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF * Is sufficiently ambulatory and capable of self care as necessary to complete study procedures * Has normal cognitive function * Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study * If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant * Is willing and able to comply with the conditions and requirements of the study Exclusion Criteria: * Has a significant risk of suicide * Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder * Has active or a history of central nervous system malignancy * Has other medically significant conditions rendering unsuitability for the study * Has used or will need to use prohibited medications or therapies * Has a known sensitivity or intolerance to study intervention or potential rescue medications

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Conditions

The condition(s) this trial relates to.

adjustment disorder amyotrophic lateral sclerosis anxiety disorder cancer Depression idiopathic pulmonary fibrosis multiple sclerosis neoplasm Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adjustment disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alliance for Multispecialty Research Clinical

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Cedar Clinical Research Inc.

    RECRUITING

    Draper, Utah, 84020, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44113, United States

    Contact Email: •••••@•••••

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dell Medical School, University of Texas at Austin

    RECRUITING

    Austin, Texas, 78712, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Hawaii Pacific Neuroscience

    RECRUITING

    Honolulu, Hawaii, 96817, United States

  • Henry Ford Health

    RECRUITING

    Novi, Michigan, 48377, United States

  • Kadima Neuropsychiatry Institute

    RECRUITING

    San Diego, California, 92037, United States

  • LSU Health Shreveport

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Providence Medical Foundation

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Roswell Park Center Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Seattle Neuropsychiatric Treatment Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Sheppard Pratt

    RECRUITING

    Towson, Maryland, 21204, United States

  • Sunstone Therapies, PC

    RECRUITING

    Rockville, Maryland, 20850, United States

    Contact Email: •••••@•••••

  • The Ohio State University, Department of Psychiatry

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • UAB, Psychiatry and Behavioral Neurology

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • UVA Center for Psychiatric Clinical Research

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Chan Medical Center

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of New Mexico, School of Medicine

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida, Department of Psychiatry and Behavioral Neuroscience

    RECRUITING

    Tampa, Florida, 33613, United States

  • University of Wisconsin at Madison

    RECRUITING

    Madison, Wisconsin, 53792, United States

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Other studies related to the condition(s) this trial covers.